NCT07416422

Onlay Mesh in Abdominal Aortic Aneurysm Repair.

No Clear Benefit With the Use of Onlay Mesh by Vascular Surgeons for Incisional Hernia Prevention in Patients With Abdominal Aortic Aneurysm Repair

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to compare the incidence of IH after abdominal aortic aneurysm (AAA) open repair according to the abdominal wall closure technique used. The main question it aims to answer is: Does prophylactic mesh reinforcement prevents from IH after AAA open repair? Patients were divided in 2 groups, fascial closure with small bites and prophylactic mesh reinforcement (Group A); and primary fascial closure with small bites alone (Group B) and were performed a clinical examination at least once within the first 24 post-operative months, where the clinical diagnosis of IH could be evaluated.

Detailed description

This study included patients treated for AAA between January 2019 and December 2021 in our institution. Two groups were evaluated, group A where patients were treated by small-bites closure plus PMR (onlay mesh) and group B where patients received primary closure with small-bites alone. The surgeries were performed as per standard of care in our department, and the decision to use the onlay mesh was per surgeon discretion. The main variable of study was the presence of incisional hernia evaluated by both clinical and image examination (at least once within the first 24 post-operative months). Patients included in the study that had any post-operative CT scan for any reason were evaluated and diagnosed with that imaging technique.For remaining patients, one radiologist with experience in ultrasound imaging performed diagnosis. A descriptive analysis of the population and variables collected was carried out using the statistical analysis package IBM SPSS statistics v22 (IBM Co).

Conditions

• Incisional Hernia of Midline of Abdomen
• Surgical Wound

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Abdominal Ultrasound or computed tomography	One radiologist with experience in ultrasound imaging performed diagnosis. This exploration was performed using a single-blind technique. Patients included in the study that had any post-operative CT scan for any reason were evaluated and diagnosed with that imaging technique

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-31
• Completion: 2023-05-30
• First posted: 2026-02-18
• Last updated: 2026-02-27

Locations

1 site across 1 country: Spain